MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 15-3 II ASSAY; TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM

Model Number CA 15-3 G2

Device Problem High Test Results (2457)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.There were no corrective/follow-up actions determined.No devices were returned this device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.Erroneous high results were generated by the cobas 8000 e 602 module.The events involved a total of 2 patients with erroneous results for cobas 8000 e 602 module.The patients' ages were requested but were not provided.The patients' weights were requested but were not provided.The patients' genders were requested but were not provided.The patients' races were requested but were not provided.The patients' ethnicities were requested but were not provided.

• Brand Name: ELECSYS CA 15-3 II ASSAY
• Type of Device: TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofferstrasse 116; na; mannheim (baden-wurttemberg), na 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8281646
• MDR Text Key: 134313999
• Report Number: 1823260-2019-90035
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CA 15-3 G2
• Device Lot Number: 270343
• Type of Device Usage: N
• Patient Sequence Number: 1